Back to resultsAllogeneic Cord Blood for Neurological Diseases in Adults
Primary Purpose
Neurological Diseases, Stroke, Spinal Cord Injuries
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Allogeneic cord blood treatment
Sponsored by
About this trial
This is an interventional treatment trial for Neurological Diseases focused on measuring Adults
Eligibility Criteria
Inclusion Criteria:
- Ischemic or hemorrhagic stroke (onset < 24 months), or
- Spinal cord injury (onset < 24 months)
Exclusion Criteria:
- Raised intracranial pressure
- Malignant cancer
- Renal failure
- Severe pulmonary dysfunction
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Allogeneic cord blood therapy
Arm Description
Allogeneic cord blood therapy
Outcomes
Primary Outcome Measures
Changes in modified Rankin Scale (mRS)
modified Rankin Scale (mRS) from 1 - 5 whereby 1 is best (no significant disability) and 5 is worst (severe disability); The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
Secondary Outcome Measures
Monitoring Adverse Events
Number of participants with treatment-related adverse events as assessedCommon by Toxicity Criteria for Adverse Events (CTCAE).version 5.0; adverse events are graded on a scale from 0 to 5, whereby grade 0 is best (no AE) and grade 5 is worst (fatal).
Full Information
NCT ID
NCT05515419
First Posted
August 18, 2022
Last Updated
November 1, 2022
Sponsor
The Medical Pavilion Bahamas
1. Study Identification
Unique Protocol Identification Number
NCT05515419
Brief Title
Allogeneic Cord Blood for Neurological Diseases in Adults
Official Title
Allogeneic Cord Blood in the Treatment of Neurological Diseases in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 3, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Medical Pavilion Bahamas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
This open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood therapy for adult patients with neurological diseases.
Detailed Description
Neurological diseases such as stroke or spinal cord injuries are very common etiologies causing disability in developed countries. Cord blood possess various stem and progenitor cells, as well as their secreted regenerative factors, and is known to repair injured brain. The investigators clinical research aims to determine the safety and efficacy of allogeneic Umbilical Cord Blood for adult patients with neurological diseases such as stroke and spinal cord injury.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurological Diseases, Stroke, Spinal Cord Injuries
Keywords
Adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
allogeneic cord blood for adult patients with neurological diseases
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Allogeneic cord blood therapy
Arm Type
Experimental
Arm Description
Allogeneic cord blood therapy
Intervention Type
Biological
Intervention Name(s)
Allogeneic cord blood treatment
Intervention Description
Allogeneic cord blood treatment
Primary Outcome Measure Information:
Title
Changes in modified Rankin Scale (mRS)
Description
modified Rankin Scale (mRS) from 1 - 5 whereby 1 is best (no significant disability) and 5 is worst (severe disability); The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
Time Frame
1 month - 3 months - 6 months - 12 months
Secondary Outcome Measure Information:
Title
Monitoring Adverse Events
Description
Number of participants with treatment-related adverse events as assessedCommon by Toxicity Criteria for Adverse Events (CTCAE).version 5.0; adverse events are graded on a scale from 0 to 5, whereby grade 0 is best (no AE) and grade 5 is worst (fatal).
Time Frame
1 month - 3 months - 6 months - 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ischemic or hemorrhagic stroke (onset < 24 months), or
Spinal cord injury (onset < 24 months)
Exclusion Criteria:
Raised intracranial pressure
Malignant cancer
Renal failure
Severe pulmonary dysfunction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Conville S Brown, MD
Phone
242-356-6666
Ext
001
Email
drconvillebrown@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Corrine S Quee, MD
Phone
242-356-6666
Ext
001
Email
support@tmp-bahamas.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Conville S Brown, MD
Organizational Affiliation
The Medical Pavilion Bahamas
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Allogeneic Cord Blood for Neurological Diseases in Adults
We'll reach out to this number within 24 hrs